Home NDC 71335-0305-3 Enalapril Maleate
Product NDC 71335-0305
Requested package NDC 71335-0305-3
11-digit product format 713350305
Labeler code 71335
Product ID 71335-0305_12790031-5275-45f7-a635-d85014bbb044
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Enalapril Maleate
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application NDA018998
Marketing category NDA AUTHORIZED GENERIC
Marketing start 1985-12-24
Marketing end 0000-00-00
Substance ENALAPRIL MALEATE
Active strength 5 mg/1
Pharmacologic classes Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 27 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018998-001 VASOTEC ENALAPRIL MALEATE 5MG TABLET / ORAL AB RLD 1985-12-24 N018998-002 VASOTEC ENALAPRIL MALEATE 10MG TABLET / ORAL AB RLD 1985-12-24 N018998-003 VASOTEC ENALAPRIL MALEATE 20MG TABLET / ORAL AB RLD, RS 1985-12-24 N018998-005 VASOTEC ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB RLD 1988-07-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 5 · 168 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N018998-001 VASOTEC 5MG TABLET / ORAL AB RLD 1985-12-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018998-002 VASOTEC 10MG TABLET / ORAL AB RLD 1985-12-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018998-003 VASOTEC 20MG TABLET / ORAL AB RLD, RS 1985-12-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018998-005 VASOTEC 2.5MG TABLET / ORAL AB RLD 1988-07-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018998-001 VASOTEC 5MG TABLET / ORAL AB RLD 1985-12-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018998-002 VASOTEC 10MG TABLET / ORAL AB RLD 1985-12-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018998-003 VASOTEC 20MG TABLET / ORAL AB RLD, RS 1985-12-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018998-005 VASOTEC 2.5MG TABLET / ORAL AB RLD 1988-07-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018998-001 VASOTEC 5MG TABLET / ORAL AB RLD 1985-12-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018998-002 VASOTEC 10MG TABLET / ORAL AB RLD 1985-12-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018998-003 VASOTEC 20MG TABLET / ORAL AB RLD, RS 1985-12-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018998-005 VASOTEC 2.5MG TABLET / ORAL AB RLD 1988-07-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018998-001 VASOTEC 5MG TABLET / ORAL AB RLD 1985-12-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018998-002 VASOTEC 10MG TABLET / ORAL AB RLD 1985-12-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018998-003 VASOTEC 20MG TABLET / ORAL AB RLD, RS 1985-12-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018998-005 VASOTEC 2.5MG TABLET / ORAL AB RLD 1988-07-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018998-001 VASOTEC 5MG TABLET / ORAL AB RLD 1985-12-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018998-002 VASOTEC 10MG TABLET / ORAL AB RLD 1985-12-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018998-003 VASOTEC 20MG TABLET / ORAL AB RLD, RS 1985-12-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018998-005 VASOTEC 2.5MG TABLET / ORAL AB RLD 1988-07-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018998-001 VASOTEC 5MG TABLET / ORAL AB RLD 1985-12-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018998-002 VASOTEC 10MG TABLET / ORAL AB RLD 1985-12-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018998-003 VASOTEC 20MG TABLET / ORAL AB RLD, RS 1985-12-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018998-005 VASOTEC 2.5MG TABLET / ORAL AB RLD 1988-07-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018998-001 VASOTEC 5MG TABLET / ORAL AB RLD 1985-12-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018998-002 VASOTEC 10MG TABLET / ORAL AB RLD 1985-12-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018998-003 VASOTEC 20MG TABLET / ORAL AB RLD, RS 1985-12-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018998-005 VASOTEC 2.5MG TABLET / ORAL AB RLD 1988-07-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018998-001 VASOTEC 5MG TABLET / ORAL AB RLD 1985-12-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018998-002 VASOTEC 10MG TABLET / ORAL AB RLD 1985-12-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018998-003 VASOTEC 20MG TABLET / ORAL AB RLD, RS 1985-12-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018998-005 VASOTEC 2.5MG TABLET / ORAL AB RLD 1988-07-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018998-001 VASOTEC 5MG TABLET / ORAL AB RLD 1985-12-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018998-002 VASOTEC 10MG TABLET / ORAL AB RLD 1985-12-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018998-003 VASOTEC 20MG TABLET / ORAL AB RLD, RS 1985-12-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018998-005 VASOTEC 2.5MG TABLET / ORAL AB RLD 1988-07-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018998-001 VASOTEC 5MG TABLET / ORAL AB RLD 1985-12-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018998-002 VASOTEC 10MG TABLET / ORAL AB RLD 1985-12-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018998-003 VASOTEC 20MG TABLET / ORAL AB RLD, RS 1985-12-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018998-005 VASOTEC 2.5MG TABLET / ORAL AB RLD 1988-07-26 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-0305 ENALAPRIL MALEATE TABLET [BRYANT RANCH PREPACK] 100 Legacy NDC, 5 package rows 20220211_b5599ea7-53ea-4f3c-93a9-78e29deb833d.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71335-0305-3 71335030503 30 TABLET in 1 BOTTLE (71335-0305-3) 30 tablet 2022-02-09 0000-00-00 No No Current